Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Auxologico Italiano
• Treatments: Alendronate; Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

1. patients affected by moderate to severe PHP without instrumental (echography, neck CT, scintigraphy with Sestamibi) evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and previously surgically treated, but recidivating without instrumental evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and judged inoperable because of other pathologies

2. patients with serum total calcium between 10.5 and 12.5 mg/dl (inclusive)

3. males: age ≥50 years; females: age ≥50 years, in menopause for at least 2 years;

4. patients with reduction of bone density (T-score ≤ -2 at spine OR hip, by DXA scan)

5. informed consent signed at enrolment

Exclusion Criteria:

1. lack of informed consent;

2. presence of other diseases known to cause hypercalcemia (e.g. familial benign hypercalcemia);

3. previous or ongoing therapies interfering with calcium and bone metabolism;

4. impaired liver and/or renal function (i.e. serum aspartate aminotransferase, alanine aminotransferase and total bilirubin twice the upper limit of normal or more; creatinine clearance lower than 60 ml/min);

5. history of seizures, malignancy, myocardial infarction;

6. previous exposure to cinacalcet.